MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN LLC COVIDIEN EV3 RAPID CROSS 2.50-2.00MM X 20MM X 170CM P+A RAPID EXC BALLOON DILATA; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	A14BX025210170
Health Effect - Clinical Codes	Laceration(s) (1946); Foreign Body In Patient (2687)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Successful atherectomy and opening of the superficial femoral artery and popliteal artery occlusions (under general anesthesia).However, a balloon catheter fracture and fragmentation resulted in retained foreign object that could not be removed and necessitated surgical intervention.Multiple attempts to remove the fractured and retained fragment were performed using multiple wires and snare catheters.After review of images and discussion it was elected the patient to be taken to the operating room to undergo removal of the catheter fragment as well as repair of the common femoral artery stenosis and consideration of possible distal bypass.Added procedure included: removal of retained balloon catheter (fracture) from left popliteal artery, left common femoral endarterectomy with patch.Fda safety report id # (b)(4).

• Brand Name: COVIDIEN EV3 RAPID CROSS 2.50-2.00MM X 20MM X 170CM P+A RAPID EXC BALLOON DILATA
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC / COVIDIEN LLC
• MDR Report Key: 13026044
• Report Number: MW5106137
• Device Sequence Number: 17121607
• Product Code: LIT
• UDI-Device Identifier: 00763000110871
• UDI-Public: (01)00763000110871(17)241007(10)
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2024
• Device Model Number: A14BX025210170
• Device Catalogue Number: A14BX025210170
• Device Lot Number: B278274
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White